Drug Toxicity and Adverse Drug Reactions in Children - A Brief Historical Review

Choonara, Imti; Rieder, Michael J.

doi:10.1185/146300902322125109

Cited by 47 publications

(54 citation statements)

References 41 publications

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“…Antibiotics in the neonatal period have been associated with drug toxicity-notably kernicterus in association with the use of sulphonamides and cardiovascular collapse in association with the use of chloramphenicol [40]. Neurotoxicity in association with the use of ampicillin has been reported [41].…”

Section: Discussionmentioning

confidence: 99%

Clinical pharmacokinetics of penicillins in the neonate: a review of the literature

Pacifici

Labatia

Mulla

et al. 2008

Eur J Clin Pharmacol

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Sepsis is common in neonates and a major cause of morbidity and mortality. Sixty percent of preterm neonates receive at least one antibiotic during the first week of life, with penicillins being the most frequently administered antibiotics. The clearance (Cl), serum half-life (t(A1/2)) and volume of distribution (Vd) of penicillins are different in the neonate than in the adult. As such, the pharmacokinetics of penicillins need be studied in neonates in order to optimise therapy in this age class with these drugs. The aim of this study was to review the published data on the pharmacokinetics of penicillins in the neonate in order to provide a critical analysis of the literature and, consequently, a useful tool in the hands of the physician. The bibliographic search was performed electronically using the PubMed and EMBASE databases as search engines. An initial search was performed with the keywords "pharmacokinetics", "penicillins" and "neonates". Secondly, other searches were performed using the keywords "pharmacokinetics" and "neonates", followed by the name of a single antibiotic. The search included articles up to 2007. There have been few pharmacokinetic studies on the use of penicillins in neonates. The results from those few studies that have been carried out suggest that the Cl is reduced and t(A1/2) prolonged in the neonate as compared with the more mature infant. There is little variation in Vd during the first week of life. In the premature neonate, Cl is reduced compared to the full-term infant. As postnatal age proceeds, the Cl of penicillins increases. More pharmacokinetic studies are required to provide a sound scientific basis for planning a dosage regimen with penicillins in the neonate

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Section: Discussionmentioning

confidence: 99%

Clinical pharmacokinetics of penicillins in the neonate: a review of the literature

Pacifici

Labatia

Mulla

et al. 2008

Eur J Clin Pharmacol

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“…På 50-tallet erfarte man også at antibiotikabehandling av nyfødte med henholdsvis sulfafurazole og kloramfenikol førte til alvorlig form for gulsott og «grey baby syndrome». Dette var betinget i metabolske faktorer spesifikke for nyfødte (5). Endring i administrering av et…”

Section: Bivirkningerunclassified

Å forske på barns premisser

Grindheim¹,

Håpoldøy²

2014

Journalisten

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“…The 20th century history of drug research and regulation shows that dramatic tragedies such as sulfanilamide (Wax, 1995), thalidomide (Choonara & Rieder, 2002) and TGN 1412 (Suntharalingam et al, 2006) cases facilitated the passage of stronger laws. The elixir of sulfanilamide case can be considered one of the earliest example of disaster in paediatric medicine therapy.…”

Section: Non Clinical: the Need Of Studies On Juvenile Animals In Ordmentioning

confidence: 99%

“…Since diethylene glycol is highly toxic causing gastrointestinal, metabolic, renal and hepatic failure, more than one hundred Americans, many of them children, died and this incident was the main cause of passage, in 1938, of the USA federal Food, Drug, and Cosmetic Act. Other incidents, since then, have induced serious adverse reactions in children (Choonara & Rieder, 2002) The Directive requires that researches/investigators and sponsors ensure ethical review, the authorization by competent national authorities before enrolling participants, the drug manufacture in compliance with Good Manufacturing Practice (GMP), and rigorous observance of the Good Clinical Practice (GCP) principles during the conduction of the trial. Furthermore, the Directive requires that any changes related to the execution of the clinical study, and its final results, be reported to the supervising authorities.…”

Section: Non Clinical: the Need Of Studies On Juvenile Animals In Ordmentioning

confidence: 99%

Changes in Research and Development of Medicinal Products since the Paediatric Regulation

Ceci¹,

Catapano²,

Manfredi³

et al. 2011

Drug Development - A Case Study Based Insight Into Modern Strategies

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Drug Toxicity and Adverse Drug Reactions in Children - A Brief Historical Review

Cited by 47 publications

References 41 publications

Clinical pharmacokinetics of penicillins in the neonate: a review of the literature

Clinical pharmacokinetics of penicillins in the neonate: a review of the literature

Å forske på barns premisser

Changes in Research and Development of Medicinal Products since the Paediatric Regulation

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